Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611306
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
BEAT-Breast Trial of DE-iPTV in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
BEAT-Breast - Improving Outcomes for Breast Cancer Patients With Brain Metastases a Pilot Nonrandomised Single Arm Phase 2 Clinical Trial in Patients With Primary Breast Cancer With Brain Metastases Who Are Not Suitable for Stereotactic Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BEAT-Breast
Brief Summary:
The aim of this study is to demonstrate if it is possible to delivering a novel and modern radiotherapy approach Dose Escalated internal PTV DE-iPTV and to collect health related quality of life in patients whose breast cancer has spread to the brain brain metastases at 8 weeks post enrolling into the study
The main questions that have been set out to to answer are
Is it possible to deliver the novel radiotherapy approach DE-iPTV
Is it possible to measure health -related quality of life
What impact does the novel radiotherapy approach have on patients quality of life control of the brain metastasis control of the lesion and steroid use
Participants will
Receive 5 doses of radiotherapy
Complete weekly quality of life EQ-5D assessments and medication steroid diaries via telephone postal until 12 weeks post enrolment
Be reviewed in clinic with up-to-date MRI scans at 8 12 and 24 weeks post-enrolment
Complete a more detailed HRQoL panel of assessments will be assessed at baseline 8 weeks 12 weeks and 24 weeks post enrolment
The main questions that have been set out to to answer are
Is it possible to deliver the novel radiotherapy approach DE-iPTV
Is it possible to measure health -related quality of life
What impact does the novel radiotherapy approach have on patients quality of life control of the brain metastasis control of the lesion and steroid use
Participants will
Receive 5 doses of radiotherapy
Complete weekly quality of life EQ-5D assessments and medication steroid diaries via telephone postal until 12 weeks post enrolment
Be reviewed in clinic with up-to-date MRI scans at 8 12 and 24 weeks post-enrolment
Complete a more detailed HRQoL panel of assessments will be assessed at baseline 8 weeks 12 weeks and 24 weeks post enrolment
Detailed Description:
Brain metastases from breast cancer are a common and devastating complication with survival times of 3 - 5 months from diagnosis
The main treatment approaches to brain metastases are surgery stereotactic radiosurgery SRS and whole brain radiotherapy However it is known that most patients with brain metastases receive either whole-brain radiotherapy WBRT or no treatment with relatively low rates of surgery and SRS Since the commonest treatment in those who do have treatment is WBRT the local team have developed an approach that is believed to be possibly more effective than WBRT The objective is to evaluate this approach in patients who are not suitable to receive more aggressive treatment and who would otherwise receive WBRT The local approach involves using a modern radiotherapy planning approach combined with careful intra-metastasis dose escalation Dose Escalated internal PTV DE-iPTV to deliver a higher dose to tumour while delivering less dose to the brain The combination of less dose to normal structures and more dose to the lesion will hopefully improve Health-related Quality of Life HRQoL
The aim of this study is to demonstrate the feasibility of delivering complex radiotherapy dose escalated internal PTV DE-iPTV and measuring quality of life at 8 weeks post-enrolment for patients with brain metastases from breast cancer who would otherwise receive WBRT An exploratory blood-based biomarker sample collection and analysis will be completed Furthermore linked national cancer data will be used to measure the number of patients currently offered WBRT including survival costs and hospital admissions and thus provide a baseline to estimate the impact of this novel approach
The main treatment approaches to brain metastases are surgery stereotactic radiosurgery SRS and whole brain radiotherapy However it is known that most patients with brain metastases receive either whole-brain radiotherapy WBRT or no treatment with relatively low rates of surgery and SRS Since the commonest treatment in those who do have treatment is WBRT the local team have developed an approach that is believed to be possibly more effective than WBRT The objective is to evaluate this approach in patients who are not suitable to receive more aggressive treatment and who would otherwise receive WBRT The local approach involves using a modern radiotherapy planning approach combined with careful intra-metastasis dose escalation Dose Escalated internal PTV DE-iPTV to deliver a higher dose to tumour while delivering less dose to the brain The combination of less dose to normal structures and more dose to the lesion will hopefully improve Health-related Quality of Life HRQoL
The aim of this study is to demonstrate the feasibility of delivering complex radiotherapy dose escalated internal PTV DE-iPTV and measuring quality of life at 8 weeks post-enrolment for patients with brain metastases from breast cancer who would otherwise receive WBRT An exploratory blood-based biomarker sample collection and analysis will be completed Furthermore linked national cancer data will be used to measure the number of patients currently offered WBRT including survival costs and hospital admissions and thus provide a baseline to estimate the impact of this novel approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None